ISO 13485:2016 Implementation Plan

[gunnyshore]

I was asked by our CEO to put together a detailed project plan for implementing ISO 13485:2016 before end of next year.
Instead of recreating the wheel, I wanted to ask the group if anyone had something they could share to help me get going?

I will share the final project plan with the group once it's completed.

thanks!
Gunny

 

[gretzles]

what is your starting point? do you have ISO 13485:2003 already, or 9001, or are you starting from scratch?

 

[gunnyshore]

We are starting from scratch, nothing is in place.

Any suggestions?
Jim

 

[gretzles]

I'm doing the same thing. I haven't done my plan yet, but I'm thinking of start by documenting the existing processes.
I'm going to work on two streams. one stream will be writing the high level procedures (risk management, document control, records control, change control to begin with). the other stream will be working with production on product realisation processes.
When we have some control over what is currently being done and control over the changes being made, I will work on the other procedures (design control, suppliers etc).
This plan is likely to change when I start trying to implement it.

 

[gunnyshore]

I was just reading an article on greenlight.guru this morning regarding "bootstrapping your QMS" and the four procedures you mentioned were the four they recommended to start with...coincidental or just great minds thinking alike. Kudos to you!

We are a small company and not much QMS-related experience on the team except me. I'm putting together a plan that will assign process owners and have them involved in creating the process. I'll lead but they need to have buy-in and be accountable. It will also help them learn the CFR and standards, better than listening to me and death by powerpoint.

Where is your company in the product development life cycle? Sounds like you have some activity going on already but not completely documented.

Gunny

 

[gretzles]

ha, I just keep adding to my list of what procedures I need. I also thinking I should include quality planning to document this project.

Your plan of getting buy-in from others is great. Everyone needs to understand what is important for their processes.

The company I am working with has been in operation for a long time, but medical devices haven't been their core business. The problem I have is that so far any additional requirements are seen as my job. I'll have a bit of work in getting them to own the changes we need to make.

The other things to start thinking about are the quality policy and quality objectives. I've found it hard to get management to set this direction even when I worked with a company that had a long established quality system.
If you're working with a small group with good commitment it might be easier to think about the direction for the company. This could help you identify find the key processes.